CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00099151
First received: December 8, 2004
Last updated: December 9, 2009
Last verified: December 2004

December 8, 2004
December 9, 2009
March 2002
May 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00099151 on ClinicalTrials.gov Archive Site
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CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy
Metabolic Adaptations to Six Month Caloric Restriction

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.

This study tests whether chronic caloric restriction improves risk factors of longevity in humans as it is known to do in animals, by measuring a variety of factors dealing with metabolism and oxidative stress, through physical evaluations and laboratory tests.

Participants will receive dietary counseling and free medical evaluations. In addition, each volunteer will be asked to do one of the following:

  1. Follow a reduced calorie diet
  2. Follow a reduced calorie diet using a liquid diet
  3. Increase physical activity while on a reduced calorie diet
  4. Follow a standard diet.

Three separate five-day inpatient stays are required.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Aging
  • Cardiovascular Disease
  • Diabetes Mellitus
  • Behavioral: Caloric Restriction (CR)
  • Behavioral: Exercise
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Resident of greater Baton Rouge area for 1 year or longer
  • Men between ages 25-50
  • Women between ages 25-45
  • Body Mass Index (BMI) between 25-30 (never having had BMI greater than 32)
  • Healthy, non-smokers with no history of cardiovascular disease, high blood pressure, diabetes, eating disorder, or major psychiatric disorder

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Personal history of cardiovascular disease or elevated high blood pressure (higher than 160/90 mmHg)
  • Abnormal electrocardiogram (EKG)
  • Personal history of diabetes
  • Personal history of major psychiatric disorders
  • Personal history of eating disorder
  • Smoking
  • Exercising regularly (more than twice a week)
  • Individuals with alcoholism or other substance abuse
  • Post obese (never have had a BMI greater than 32)
  • Regular use of medications, except oral contraceptives
  • Individuals who were ever injured by a metallic foreign body which was not removed
  • Individuals who wear braces on their teeth, have non-removable false teeth, or non-removable bridgework
  • Individuals in occupations requiring full alertness and motor skills (airline pilots, etc.) where even a small chance of postural dizziness would be unacceptable.
Both
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099151
AG0005, 5U01AG020478-02
Not Provided
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National Institute on Aging (NIA)
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Principal Investigator: Eric Ravussin, Ph.D. Pennington Biomedical Research Center
Principal Investigator: Donald Williamson, Ph.D. Pennington Biomedical Research Center
National Institute on Aging (NIA)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP